Assessment of Neural Signals for the Control of Assistive Devices

Not Applicable

Not yet recruiting

• Conditions: Spinal Cord Injury (SCI), Initial Encounter
• Interventions: Procedure: Epidural Spinal Cord Stimulation; Device: Electrocorticographic; Device: Electroencephalographic

• Registration Number: NCT06533969
• Lead Sponsor: University of Miami

Brief Summary

The study will investigate the use of motor intention-based cortical signals to trigger epidural spinal cord stimulation (ESCS) with individuals with SCI. Motor intention of UL tasks will be decoded using brain-computer interface (BCI) system based on cortical signals recorded using an Electroencephalographic (EEG) system or using their intracranially implanted devices Electrocorticographic (ECoG).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-25
• Study First Submitted QC: 2024-07-31
• Last Update Submitted: 2024-07-31
• Study First Posted: 2024-08-01
• Last Update Posted: 2024-08-01
• Study Start: 2024-10-01
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Patients age 18 and older
• Able to sign informed consent
• Not participating in other studies that limit participation
• Chronic (>6 month) traumatic Spinal Cord Injury (SCI) (C4-T1 neurological injury with American Spinal Injury Association Impairment Scale (AIS A-D) with some residual function.

Exclusion Criteria

• Patients that are pregnant
• Patients under the age of 18
• Patients unable to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Brain Computer Interface-Epidural Spinal Cord Stimulation (BCI-ESCS)	Electrocorticographic	Participants in this group will receive a onetime surgery to have the leads implanted temporarily for ESCS which will be triggered through the BCI system. The BCI-ESCS arms will include Upper limb (UL) therapist-guided training, with triggered through a BCI system during task practice. The BCI system will decode motor intention of Upper limb (UL) tasks from cortical signals recorded using EEG system or using their intracranially implanted devices (e.g., ECoG). Participants will perform UL daily activities (e.g., grasping, reaching) tailored to participants deficits. The therapist will facilitate task practice and progress therapy within and between session. Subjects will be involved in the intervention for up to 2 months.
Brain Computer Interface-Epidural Spinal Cord Stimulation (BCI-ESCS)	Epidural Spinal Cord Stimulation	Participants in this group will receive a onetime surgery to have the leads implanted temporarily for ESCS which will be triggered through the BCI system. The BCI-ESCS arms will include Upper limb (UL) therapist-guided training, with triggered through a BCI system during task practice. The BCI system will decode motor intention of Upper limb (UL) tasks from cortical signals recorded using EEG system or using their intracranially implanted devices (e.g., ECoG). Participants will perform UL daily activities (e.g., grasping, reaching) tailored to participants deficits. The therapist will facilitate task practice and progress therapy within and between session. Subjects will be involved in the intervention for up to 2 months.
Brain Computer Interface-Epidural Spinal Cord Stimulation (BCI-ESCS)	Electroencephalographic	Participants in this group will receive a onetime surgery to have the leads implanted temporarily for ESCS which will be triggered through the BCI system. The BCI-ESCS arms will include Upper limb (UL) therapist-guided training, with triggered through a BCI system during task practice. The BCI system will decode motor intention of Upper limb (UL) tasks from cortical signals recorded using EEG system or using their intracranially implanted devices (e.g., ECoG). Participants will perform UL daily activities (e.g., grasping, reaching) tailored to participants deficits. The therapist will facilitate task practice and progress therapy within and between session. Subjects will be involved in the intervention for up to 2 months.

Primary Outcome Measures

Name	Time	Method
Change in Hand Motor Evoked Potential (MEP)	Baseline, up to 2 months post-implant	Change in Motor Evoked Potential (MEP): MEP evaluates corticospinal excitability (strength of the connections between the brain and the muscles). The excitability is measured as a peak-to-peak amplitude in millivolts (mV).
Change in Hand Motor Function	Baseline, up to 2 months post-implant	Toronto Rehabilitation Institute Hand Function Test (TRI-HFT): Measured on a scale from 0-133 to assess upper extremity manipulation and grip force at time points before and after implant.; Higher scores indicate better hand motor function.

Secondary Outcome Measures

Name	Time	Method
Change in Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP)	Baseline, up to 2 months post-implant	Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP): Standardized test to be measured on a scale from 0-116 through the combination of five subset scores to assess grasping ability at time points before and after implant. A composite score will be obtained for strength, muscle force and tasks.; Higher scores indicate better hand motor function.
Change in Muscle Coordination Measured by Electromyography (EMG)	Baseline, up to 2 months post-implant	Functional tasks: Assessments to measure reaching ability and obtain muscle coordination via EMG (millivolts).
Change in Quality of Life	Baseline, up to 2 months post-implant	Quality of Life using the International Spinal Cord Injury - Quality of Life (ISCI-QOL): ISCI-QOL consists of three single items on satisfaction with life as a whole, physical health, and psychological health using a 0-10 scale where 0=complete dissatisfaction; 10=complete satisfaction.; A composite score will be obtained for this measure.
Change in Satisfaction of Life	Baseline, up to 2 months post-implant	Medical Outcomes Study Short Form 36 (SF-36): Patient-reported outcome measurement for health-related quality of life and activities of daily living scored on a scale of 0 (negative health) to 100 (positive health).
Change in Movement Kinematics	Baseline, up to 2 months post-implant	Kinematics data (motion capture, measured in centimeters) at time points before and after implant.
Change in Pain Levels	Baseline, up to 2 months post-implant	Brief Pain Inventory (BPI): A questionnaire for pain will be assessed on a scale of 0 ("no pain") to 10 ("worst imaginable pain") at different points before and after the implant.
Change in Muscle Strength	Baseline, up to 2 months post-implant	Muscle force testing: Assessment of changes in muscle strength from measured in Newtons at time points before and after implant.
Change in Independence Measured by Spinal Cord Independence Measure (SCIM III)	Baseline, up to 2 months post-implant	Independence as measured by Spinal Cord Independence Measure (SCIM III): SCIM III assesses performance in activities of daily living Scores range from 0-100, where a score of 0 defines total dependence and a score of 100 is indicative of complete independence.

Trial Locations

Locations (2)

The Miami Project to Cure Paralysis; 🇺🇸 Miami, Florida, United States

Lynn Rehabilitation Center; 🇺🇸 Miami, Florida, United States